NEW YORK STATE DEPARTMENT OF HEALTH

1 NEW york STATE DEPARTMENT OF HEALTH BUREAU OF NARCOTIC ENFORCEMENT License Application to Engage in a Controlled Substance Activity Instructions New Renewal Amendment Instructions for Form DOH-4330 [Instructions and Application are available on the DOH Web site as separate downloads] New york STATE DEPARTMENT of HEALTH Bureau of Narcotic Enforcement Riverview Center 150 Broadway Albany, New york 12204 (866) 811-7957 February 2017 NEW york STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement LICENSE APPLICATION to ENGAGE in a CONTROLLED SUBSTANCE ACTIVITY Public HEALTH Law (PHL) requires any person acting as a manufacturer, distributor, importer, exporter, institutional dispenser or institutional dispenser limited of controlled substances, or conducting research, instructional activities or chemical analysis with controlled substances in New york STATE to obtain a license from the DEPARTMENT of HEALTH (DOH).

2 In order to obtain a controlled substance license, you must submit a License Application to Engage in a Controlled Substance Activity (DOH-4330) to the DOH Bureau of Narcotic Enforcement (BNE). The application will document that you have satisfied the licensing requirements as outlined in PHL Article 33 and the Part 80 Rules and Regulations on Controlled Substances in New york STATE , both of which can be found on the DOH Web site at This package outlines the general requirements for a controlled substance license. It does not present the requirements in their entirety. It is incumbent upon the applicant to fully familiarize him/herself with all applicable Sections of PHL Article 33 and Title 10 NYCRR Part 80. INSTRUCTIONS 1. Read these instructions and the License Application to Engage in a Controlled Substance Activity in their entirety before completing your application.

3 2. Complete the application as follows (please print or type). APPLICANT INFORMATION Enter the applicant information as it should appear on your license. The address is the address where the controlled substance activity will take place. If a Box is used, a street address must also be included. If you are renewing or amending a license, enter your controlled substance license number. Licenses are name - and address - specific and are non-transferrable. Class 3 (Institutional Dispenser) and Class 3A (Institutional Dispenser, Limited) licenses shall be issued as indicated on the facility s Operating Certificate. Upon licensing and prior to engaging in controlled substance activity, all Classes (excluding 3A) must obtain a Federal Drug Enforcement Administration (DEA) registration in the equivalent classification. Said DEA registration must coincide to the licensed location.

4 Class 11 Pharmacy ADS licensees must obtain written residential HEALTH care facility specific approval from BNE prior to placing controlled substances within an ADS. CONTACT INFORMATION Enter the name, title, telephone and fax numbers and E-mail address of the contact person for the license application. APPLICATION TYPE Identify the type of application being submitted: New, Renewal or Amendment. APPLICATION TYPE New If you are submitting an application for a new license, check the corresponding box and enter the date proposed for the controlled substance activity to begin. New applicants, as well as those reporting a relocation or change in ownership (operator), will be subject to an on-site facility inspection by BNE (excluding out-of- STATE applicants). Renewal If there have been no changes to the licensee s controlled substance activity, name (legal, trade or d/b/a), ownership (operator), address and approved controlled substance schedules, check the corresponding box.

5 Amendment If you are submitting an application to amend your current license, check the corresponding box and attach to the application a narrative outlining the specific change(s) being requested. Amendments are designated as Relocation , Add a Manufacturing or Distribution Activity , Add a Controlled Substance and/or Schedule or Add a Further Activity . Dependent on the license class, a licensee may not qualify to apply for an amendment and shall be treated as an applicant for a new license. Only Class 1, 1A, 2, 2A, 9, 9A, 10 & 10A licensees are eligible to apply for a relocation Amendment , all other licensees intent on relocating controlled substance activity shall be treated as an applicant for a new license. Page 2 of 6 (2/17) NEW york STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement LICENSE APPLICATION to ENGAGE in a CONTROLLED SUBSTANCE ACTIVITY LICENSE CLASSIFICATION Identify the license classification for which you are applying.

6 Note the applicable fee. Licenses are issued in the following classifications: Class 1 Manufacturer Class 1a Manufacturer (Out-of- STATE ) Class 2 Distributor Class 2a Distributor (Out-of- STATE ) Class 3 Institutional Dispenser Class 3a Institutional Dispenser Limited Class 4 Researcher (Schedules II-V) (Individual and Institutional) Class 5 Instructional Activities (Schedules II-V) Class 7 Research and Instructional Activities (Schedule I) (Individual and Institutional) Class 8 Analytical Laboratory Class 9 Importer Class 9a Importer Broker Class 10 Exporter Class 10a Exporter Broker Class 11 Pharmacy - Automated Dispensing System A separate application and fee is required for each license classification sought. New york STATE , county and municipal agencies are exempt from licensing fees. Licenses are valid for two years from their effective date. While BNE currently provides a renewal reminder notification at least 90-days prior to a license expiration, the licensee remains responsible for filing a satisfactory renewal application pri-or to the expiration of said license.

7 SUBMISSION REQUIREMENTS All applicants currently licensed by BNE Submit Copy of current controlled substance license. All applicants registered with the New york STATE Board of Pharmacy Submit Copy of New york STATE Board of Pharmacy registration. All applicants registered with the Drug Enforcement Administration (DEA) Submit Copy of DEA registration. Class 1 1A 2 & 2A Applicants Submit Name, residential address, and title of each officer, director and any person having 10% or greater proprietary, beneficial, equitable or credit interest in the applicant. Class 1 1A 2 2A 9 9A 10 & 10A Applicants Submit List of all Schedule I controlled substances to be manufactured, distributed, imported and/or exported. Class 3 & 3A Applicants Submit Copy of facility s legal authority to operate ( , operating certificate issued by DOH, OASAS, OCFS, OMH, OPWDD, etc.)

8 In the event that the authorizing STATE agency has yet to issue the facility s operating certificate, secure and provide a letter from the authorizing STATE agency showing the temporary authority to operate pending issuance of the official operating certificate. Said written letter must identify the authorizing STATE agency, identify the owner/operator, identify the facility s name and address, and describe the type of facility to be operated. Class 4 5 & 7 Individual Researcher or Instructional Activities Applicants (PHL Section 3325 & Section ) Submit Completed Class 4 & 7 Individual Researcher Protocol (see Appendix A1) or Completed Class 5 & 7 Instructional Activities Protocol (See Appendix A2) Class 4 & 7 Institutional Researcher Applicants (PHL Section 3326 & Section ) Submit Completed Class 4 & 7 Institutional Researcher Statement (see Appendix B) Class 8 Analytical Laboratory Applicants (PHL Section 3326 & Section ) Submit Completed Class 8 Analytical Laboratory Protocol (see Appendix C) Class 11 Pharmacy ADS Applicants Submit (see Appendix D) Page 3 of 6 (2/17) NEW york STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement LICENSE APPLICATION to ENGAGE in a CONTROLLED SUBSTANCE ACTIVITY CONTROLLED SUBSTANCE SCHEDULE(S)

9 TO BE UTILIZED -- List all controlled substance schedules to be utilized. (see PHL Section 3306 for schedules of controlled substances) STORAGE OF CONTROLLED SUBSTANCES -- Identify the controlled substance storage standards that are in place at your facility and provide a description. Be sure to refer to the Controlled Substance Storage Minimum Requirements that are included as part of this package. In the event that a current licensee (excluding Classes 1A and 2A) intends to change the physical security of controlled substances, said storage must be inspected by a Bureau Narcotic Investigator and approved by the Bureau of Narcotic Enforcement prior to implementation to ensure the storage meets minimum security standards. Written notification, including a description of the intended storage, is to be made to New york STATE DEPARTMENT of HEALTH , Bureau of Narcotic Enforcement, Riverview Center, 150 Broadway, Albany, NY 12204 or SUPERVISOR OF CONTROLLED SUBSTANCE ACTIVITY -- If an individual other than you (as the applicant or authorized representative) will be supervising the controlled substance activity, provide the application to that person and ask that he/she enter his/her name, title and type of professional license and number, and sign it.

10 APPLICANT ACKNOWLEDGEMENTS -- Read the applicant acknowledgements and answer each question presented. Applicants who answer YES to any of the questions must submit a statement of explanation with documentation to support the explanation. APPLICANT (OR AUTHORIZED REPRESENTATIVE) SIGNATURE -- Enter your name and title; sign and date. 3. Make a copy of your application and all supporting information/documentation for your records. Send the application, along with the requisite fee (if applicable) in the form of a check or money order made payable to the New york STATE De-partment of HEALTH , Bureau of Narcotic Enforcement, as well as any other information/documentation required, ad-dressed to: New york STATE DEPARTMENT of HEALTH Bureau of Narcotic Enforcement Riverview Center 150 Broadway Albany, New york 12204 **If you are licensed and no longer engage in controlled substance activity, you must notify the Bureau of Narcotic Enforcement immediately** APPLICATION CHECKLIST Did you remember to: Read the applicant acknowledgements then complete, sign and date the application?